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IRCT20220516054879N7 IRCT 2023-07-09 Rasht University of Medical Sciences The Effect of N-Acetyl cysteine on Cognitive performance Impairment The Effect of N-Acetyl cysteine on Cognitive performance Impairment During Electro Convulsive Therapy in Patients with Bipolar disorder 2023-05-26 anticipated 52 Complete https://irct.ir/trial/70362 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization will be performed by blocks of size 4, using sealedenvelope.com website. For allocation concealment, opaque envelopes sealed with a random sequence (snose) will be used, Blinding description: In this triple-blinded study, the patient, the investigator, and the data analyzer were blinded to the studied groups. Sealed envelopes for randomization, drug and placebo in similar envelopes are provided to the nurse of the department and when the patient enters, the medicine or placebo is given to the patient based on the code written in the envelope.The patient and the researcher do not know about the treatment group, and only the ward nurse and the patient's caregiver know about the grouping. 3 Bipolar. Intervention 1: Intervention group: 26 Patients in the intervention group will receive one 600 mg oral n-acetyl cycteine effervescent tablet manufactured by Osve Company, every 12 hours, from 24 hours before the start of Electroconvulsive therapy (ECT) to 24 hours after the end of ECT. Usually, patients receive 6 sessions of electroconvulsive therapy, therefore, the duration of drug treatment will be two weeks. Intervention 2: Control group: 26 Patients in the control group will receive one placebo manufactured by Osve Company, every 12 hours, from 24 hours before the start of Electroconvulsive therapy (ECT) to 24 hours after the end of ECT. Usually, patients receive 6 sessions of electroconvulsive therapy, therefore, the duration of drug treatment will be two weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is According to the approval of the ethics committee of Guilan University of Medical Sciences, in order to respect the privacy of patients, there is no plan to publish the results of patients.
public Maryam Shahrokhi
17 Shahrivar Hospital, Shahid Siadati Street, Namjoo Street, Rasht
Rasht Iran (Islamic Republic of) 4144654379 +98 13 3336 9019 shahrokhi.mail85@gmail.com Rasht University of Medical Sciences scientific Maryam Shahrokhi
17 Shahrivar Hospital, Shahid Siadati Street, Namjoo Street, Rasht
Rasht Iran (Islamic Republic of) 4144654379 +98 13 3336 9019 shahrokhi.mail85@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Patients with bipolar disorder older than 18 years Treatment with electroconvulsive therapy 18 years no limit Both Schizophrenia Drug Abusers Psychiatric diseases with other mental illnesses Bradyarrhythmia Liver or kidney failure History of seizures Drug or alcohol use History of asthma or bronchospasm History of allergy to n-acetyl cycteine Pregnancy Breastfeeding Currently uncontrolled hypertension Active peptic ulcer Receiving nitroglycerin History of severe skin disease such as Steven Johnson F31 Bipolar disorder Treatment - Drugs Placebo Intervention group: 26 Patients in the intervention group will receive one 600 mg oral n-acetyl cycteine effervescent tablet manufactured by Osve Company, every 12 hours, from 24 hours before the start of Electroconvulsive therapy (ECT) to 24 hours after the end of ECT. Usually, patients receive 6 sessions of electroconvulsive therapy, therefore, the duration of drug treatment will be two weeks. Control group: 26 Patients in the control group will receive one placebo manufactured by Osve Company, every 12 hours, from 24 hours before the start of Electroconvulsive therapy (ECT) to 24 hours after the end of ECT. Usually, patients receive 6 sessions of electroconvulsive therapy, therefore, the duration of drug treatment will be two weeks. Cognitive impairment. Timepoint: Before intervention and two weeks after beginning of the intervention. Method of measurement: Mini-Mental State Examination questionnaire. Systolic blood pressure. Timepoint: Before the intervention and two weeks after beginning of the intervention. Method of measurement: Digital blood pressure measurement device. Diastolic blood pressure. Timepoint: Before the intervention and two weeks after beginning of the intervention. Method of measurement: Digital blood pressure measurement device. Rasht University of Medical Sciences Approved 2023-05-17 Ethics Committee of Guilan University of Medical Sciences Research and Technology Deputy , in front of 17 Shahrivar Hospital , Shahid Siadati St , Namjo St , Rasht Town. Rasht Guilan Iran (Islamic Republic of)